How Using the Right Particle Size Analyzer Can Improve Pharmaceutical Products in Indonesia

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Indonesia, with a population of more than 260 million, is currently the largest pharmaceutical market in ASEAN and among the fastest growing in Asia. With over 210 drug manufacturers and 30,000 medicinal plants in the country, this industry will only get larger.

Research firm Global Data has estimated that the overall Indonesian market will exceed USD 10 billion by 2021. With a fast-growing market size and an increasing number of players, this will generate intense competition between manufacturers. This means that only by having the best products can businesses remain competitive.

As such, enhancing product development and maximizing production efficiency is, therefore, key to leading and winning the race; and this starts at the beginning of the production process, from the raw material right through the entire development cycle.

For instance, Dexa Medica, among the largest Indonesian pharmaceutical companies with a presence in various ASEAN markets, invested in a particle size analyzer system for its production line. The equipment ensures the drugs’ stability and reliability. Producing a consistent high-standard of compliance and production precision allows Dexa Medica to position itself one of the largest Indonesian pharmaceutical manufacturers.

In Indonesia, drug evaluation usually takes between 100 and 300 working days to be completed by the Badan Pengawas Obat dan Makanan (BPOM), the national agency for food and drug controls.

The agency abides by the U.S Food and Drug Administration’s standard measurement and guidance, which cover the mandatory specific tests and criteria for drugs’ particle size. The acceptance criteria include a number of rate of total particles in a drug’s given size range, which means the upper and/or lower particle size limits should be clearly defined.

For businesses, it is critical to be sure that all drugs submitted for certification are following the national regulation and that all supporting documentation are available for health authorities to refer to and proceed to register the product. This can also greatly shorten your lead time to market.

Besides fulfilling the compliance requirements, particle size and size distribution have a direct influence on a finished product such as reaction rate, dissolution rate, packing density, appearance and texture. For solids, the size distribution of the particle is critical in determining the rate of a chemical reaction as well as the dissolution rate.

Particle size can affect a substance’s dissolve rate. Smaller particles have a smaller surface area, therefore making dissolution occur more quickly. Water-soluble drugs also dissolve at a faster rate if they have a smaller particle size.

Particles above a certain size are filtered out of the respiratory system to avoid any potential damage to the lungs. Nanoparticle Tracking Analysis (NTA) helps characterize nanoparticles from 0.01 – 1 µm in solution. This methodology produces high resolution results for nanoparticle size distribution and concentration, while visual validation provides users with additional confidence in their data. NTA can be used to develop targeted drug delivery systems.

As particle analyzers use many different techniques to arrive at measurements, manufacturers considering buying or upgrading their particle size analyzer equipment will need to ask themselves what technique will work best for their intended application.

The key factors to take into consideration when choosing the right solution include:

What exactly do you want to measure and why?
What is the size range to be measured?
In what “state” should the measurements be made?
What are the instruments needed to achieve the finished product quality?
Do they meet international standards and are they in compliance with local regulations?
Are you trying to characterize different particle types in a single sample?
Is measuring the count or concentration of the particles along with size/shape important?
How easy is it to generate reliable data?

You may also want to consider the after-sales service engineering offered by your business partner, as well as their assured response time in possible production downtime.

With a fast-growing middle class and a rapidly aging population, the demand for good quality pharmaceutical products and reliable healthcare services will continue to rise in Indonesia. Manufacturers who understand it and are multiplying efforts to achieve product quality and compliance are likely to grow in this exciting environment.

To help companies looking to answer all the above questions, DKSH can help you to identify those business needs. Partnering with leading brands for years, we have the right equipment and provide free testing for micronized and nano-size samples. We also provide support in methods development to our customers.

If your business is looking at how a particle size analyzer can help improve the quality of your pharmaceutical products in Indonesia, do drop me a note.